- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04563624
Clinical Assessment of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up
September 24, 2020 updated by: Haneen ahmed shafik elmoselhy, Cairo University
Clinical Assessment Accourding to Modified Usphs"of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up Randomized Clinical Trial
The aim of the study is to compare one-year clinical performance of indirect restoration fabricated from nano hybrid composite CAD CAM blocks and ceramic blocks
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This research is conducted for comparing the clinical efficacy of nano hybrid composite blocks and ceramic blocks ., the choice of nano hybrid composite blocks based on the claim of the manufacturer, as it's considered to be promising , nano hybrid composite blocks has the highest fillers content (86% by weight), resembles natural teeth perfectly , Excellent physical values for flexural strength and abrasion, No firing required (a real one step ), can be processed using any conventional milling unit, can be finished and polished optimally, Ideal for grinding even in cases with thin edges.
Study Type
Interventional
Enrollment (Anticipated)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with badly broken vital teeth
- Young adult Males or female
- Good oral hygiene measures
- Cooperative patients approving to participate in the study
Exclusion Criteria:
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Severe medical complications
- Lack of compliance
- Endodontically treated teeth
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ceramic cad cam blocks
|
ceramic cad cam blocks
|
|
Active Comparator: composite cad cam blocks
|
cad cam composite blocks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marginal integrity
Time Frame: one year
|
using usphs visual inspection
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
November 1, 2020
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
September 20, 2020
First Submitted That Met QC Criteria
September 23, 2020
First Posted (Actual)
September 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2020
Last Update Submitted That Met QC Criteria
September 24, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13919991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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